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510(k) K070915

SAPIMED DISPOSABLE SIGMOIDOSCOPE by Sapimed S.P.A. — Product Code KDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2007
Date Received
April 2, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sigmoidoscope, Rigid, Non-Electrical
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Sapimed S.P.A.

  • K070881 — LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 (September 26, 2007)
  • K070913 — SELF-LIGHT DISPOSABLE ANOSCOPE (August 10, 2007)